BEUDAMED
    FDA Recall Terminated

    N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539

    Recall: Z-2341-2019 · Initiated June 27, 2019

    Recall

    Recall Number
    Z-2341-2019
    Event Number
    83311
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JZW
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 27, 2019
    Terminated
    May 27, 2020
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539

    Reason

    Iincreased (falsely elevated) Albumin results compared to expected results

    Action

    Siemens Healthcare Diagnostics issued Urgent Medical Device Correction (UMDC) letter PP-19-002.A.US to the US customers June 27, 2019 and May 2019 via FedEx overnight delivery and email to regional countries for implementation Outside the US (OUS). Customers were instructed to contact their Siemens Healthineers Customer Care Center for further follow-up in case they experienced sporadically increased Albumin results compared to expected results. Customers were also instructed to complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days.

    Distribution

    Nationwide

    Quantity

    664 units